(255 days)
Not Found
Not Found
No
The 510(k) summary describes a ceramic femoral head for hip replacement, a purely mechanical device. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as a component of a total hip arthroplasty, which is a surgical procedure intended to provide increased patient mobility and reduce pain by replacing a damaged hip joint. This directly addresses medical conditions and aims to restore normal function, fitting the definition of a therapeutic device.
No
Explanation: The provided text describes a medical device, a ceramic femoral head, used in total hip arthroplasty. Its intended use is to replace a damaged hip joint, not to diagnose a condition. The descriptions focus on the device's physical properties and its role in reconstructive surgery, with no mention of diagnostic functions or capabilities.
No
The device description clearly states it is a ceramic femoral head, which is a physical implantable component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (a ceramic femoral head) used in total hip replacement surgery. This device is implanted directly into the patient's body to replace a damaged joint component.
- Intended Use: The intended use clearly states that the device is used to "provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation." This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided about the device's material, size, and how it attaches to other components further confirms its nature as a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint atticulation in patients where there is evidence of sufficient replacing the unmaged the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Product codes
LZO
Device Description
The DePuy Ceramic Femoral Heads are available in a diameter of 28mm, with various offset options. The internal bore which is designed to interlock with the external taper on DePuy femoral stems is available in two variations. The Ceramic Heads are intended to attach to femoral stems, thereby providing the femoral articular surface of a total hip replacement. The DePuy Ceramic Femoral Heads are made from an alumina composite material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Ceramic Articul/eze Femoral Balls, S-ROM Ceramic Femoral Heads
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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011533 page 1 of 1
Image /page/0/Picture/1 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a solid black circle to the left of the name "DePuy" in a bold, sans-serif font, also in black. Below the name, in a smaller font, is the text "a Johnson-Johnson company". The logo is simple and professional, conveying a sense of stability and trust.
SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 8 2002 DePuy Orthopaed PO Box 988 DePuy Orthopaedics, Inc. NAME OF FIRM: 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988 USA 700 Orthopaedic Drive Tel: +1 (219) 267 8143 Warsaw, IN 46581-0988 Fax: +1 (219) 267 7196 510(k) CONTACT: Janet G. Johnson Group Leader. Regulatory Affairs TRADE NAME: DePuy Femoral Heads COMMON NAME: Ceramic Femoral Ball Prosthesis CLASSIFICATION: 888.3353 Hip joint metal/ceramic/polymer, semiconstrained cemented or nonporous uncemented prosthesis DEVICE PRODUCT CODE: 87 LZO SUBSTANTIALLY EQUIVALENT DEVICES: Ceramic Articul/eze Femoral Balls, S-ROM Ceramic Femoral Heads
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Ceramic Femoral Heads are available in a diameter of 28mm, with various offset options. The internal bore which is designed to interlock with the external taper on DePuy femoral stems is available in two variations. The Ceramic Heads are intended to attach to femoral stems, thereby providing the femoral articular surface of a total hip replacement. The DePuy Ceramic Femoral Heads are made from an alumina composite material.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Ceramic Femoral Heads are identical in design and indications to the ceramic femoral heads that were cleared previously. Testing has shown that the minor adjustments do not affect the performance of the device.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janet G. Johnson Group Leader, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
JAN 2 8 2002
Re: K011533 Trade/Device Name: DePuy Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer, semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: November 9, 2001 Received: November 13, 2001
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Janet G. Johnson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 1
510(k) Number (if known) KO11533
Device Name DePuy Femoral Heads
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint atticulation in patients where there is evidence of sufficient replacing the unmaged the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Concurrence of CDRH, Office of Device Evaluation
/ Mark A. Melkerson
Division Sign-Off) (Division of General, Restorative and Neurological Devices
eurological Device
Number
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
00004